(212 days)
The disposable medical surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided as sterile and non-sterile.
The surgical mask consists of a mask body, a nose piece, and ear loops. The mask body is divided into three layers, the inner and outer layers are made of polypropylene fabrics; the middle layer is composed of Melt-blown cloth (polypropylene); the nose piece is made of polypropylene & iron (Fe), and the ear loops are made of nylon & spandex.
The provided document is a 510(k) Premarket Notification for a Disposable Medical Surgical Mask. This type of device is a physical product and not an AI/ML software device. Therefore, the questions regarding AI/ML specific criteria (such as training sets, ground truth establishment methods, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.
The document details the acceptance criteria and a study proving the device meets these criteria for a medical mask. The study focuses on bench testing and biocompatibility testing, which are standard for physical medical devices of this type.
Here’s the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test Methodology (standard) | Purpose | Acceptance Criteria | Results (for both sterile and non-sterile masks, as they show very similar results in the combined summary table) |
|---|---|---|---|
| ASTM F 1862-17 | Fluid Resistance Performance | 29 out of 32 pass at 160 mmHg | Lot 1# pass at 160mmHg;Lot 2# pass at 160mmHg;Lot 3# pass at 160mmHg |
| ASTM F2101-19 | Bacterial Filtration Efficiency | ≥ 98% | Lot 1# 99.6%-99.9%;Lot 2# 99.7%-99.9%;Lot 3# 99.6%-99.9% |
| EN 14683: 2019 | Differential Pressure (Delta-P) | < 6.0 mm H2O/cm² | Lot 1# 4.0-5.2;Lot 2# 4.4-5.4;Lot 3# 3.6-5.2 |
| ASTM F2299-2007 | Particulate Filtration Efficiency Performance | ≥ 98% | Lot 1# 98.0%-98.9%;Lot 2# 98.3%-98.9%;Lot 3# 98.3%-98.9% |
| 16 CFR Part 1610 | Flammability | Class I | Lot 1# Class I;Lot 2# Class I;Lot 3# Class I |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the subject device was non-cytotoxic |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under the conditions of the study, the subject device was non-sensitizing |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, the subject device was non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance (ASTM F 1862-17): The acceptance criteria states "29 out of 32 pass at 160 mmHg," indicating a sample size of 32 units tested. The results are reported for three different lots (Lot 1#, Lot 2#, Lot 3#), suggesting batch testing.
- Other tests (Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Differential Pressure, Flammability): While specific sample sizes for these tests are not explicitly stated in the summary table, results are provided for three different "lots" (Lot 1#, Lot 2#, Lot 3#). This implies multiple samples were taken from each lot and tested to derive the reported ranges.
- Biocompatibility tests (Cytotoxicity, Sensitization, Irritation): The results are reported as meeting the criteria "Under the conditions of the study," without specific sample numbers mentioned in the summary, but these are standard lab tests typically conducted on a sufficient number of samples as per the ISO standards.
- Data Provenance: The tests were conducted by Chongqing COE Display Technology Co., Ltd. (China). The data is prospective as it's generated specifically for this 510(k) submission to demonstrate compliance with standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a physical medical device (surgical mask), not an AI/ML diagnostic tool. Ground truth is established through standardized laboratory testing protocols (e.g., ASTM, ISO) and physical measurements/observations, not human expert interpretation of images or data.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a physical device, testing involves objective laboratory measurements and adherence to pre-defined standard protocols, not human adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. MRMC studies are relevant for diagnostic devices where human readers interpret medical data (e.g., images). This device is a physical protective barrier, and its effectiveness is determined through quantifiable physical and biological barrier properties, not diagnostic accuracy by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithm or software device. Its performance is intrinsic to the device's material and design, measured in a laboratory setting.
7. The Type of Ground Truth Used
The ground truth for this device is based on objective, measurable performance criteria derived from recognized national and international standards for medical face masks and biocompatibility:
- Standardized Bench Test Measurements: e.g., Fluid Resistance (ASTM F1862), Bacterial Filtration Efficiency (ASTM F2101), Particulate Filtration Efficiency (ASTM F2299), Differential Pressure (EN 14683), Flammability (16 CFR Part 1610).
- Biocompatibility Lab Results: e.g., Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10). These involve established biological testing methods.
8. The Sample Size for the Training Set
- Not Applicable. This refers to AI/ML model development, which is not relevant for this physical device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This refers to AI/ML model development, which is not relevant for this physical device.
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April 21, 2021
Chongqing COE Display Technology Co., Ltd. % James Tsai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K202759
Trade/Device Name: Disposable medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 12, 2020 Received: September 21, 2020
Dear James Tsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence W. Murray III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202759
Device Name Disposable medical surgical mask
Indications for Use (Describe)
The disposable medical surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided as sterile and non-sterile.
Level 3, surgical mask model, sterile: CCSM-SC Level 3, surgical mask model, non-sterile: CCSM-NC
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K202759
1. Administrative Information
| Date of Summary prepared | April 17, 2021 |
|---|---|
| Applicant information | Company: Chongqing COE Display Technology Co., Ltd. |
| Company address:No. 3, Tonggui Avenue, Yufengshan Town, YubeiDistrict, Chongqing, China | |
| Contact person: Liu Qingjun | |
| Phone: 86-023-67849398 | |
| Fax: 86-023-67843279 | |
| E-mail: liuqj@szcoe.com | |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd.Address: 1713A, 17th Floor, Block A, Zhongguan TimesSquare, Nanshan District, Shenzhen |
| Contact person: James Tsai | |
| E-Mail: james_tsai@cefda.com; field@cefda.com |
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Disposable medical surgical mask |
| Classification name: | Surgical Face Mask, Apparel |
| Review Panel: | General and plastic surgery devices |
| Product Code: | FXX |
| Common name | Surgical mask |
| Device Class: | II |
| Regulation Number: | 878.4040 |
3. Predicate Device Information
| Sponsor: | SAN-M PACKAGE CO., LTD. |
|---|---|
| Device trade name: | Surgical face mask (Ear loops and Tie-on) |
| Device Class: | II |
| 510(K) Number: | K160269 |
| Regulation name | Masks, Surgical |
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| Production regulation: | 21 CFR §878.4040 |
|---|---|
| Product code: | FXX |
| Review Panel: | General and plastic surgery devices |
4. Device Descriptions
The surgical mask consists of a mask body, a nose piece, and ear loops. The mask body is divided into three layers, the inner and outer layers are made of polypropylene fabrics; the middle layer is composed of Melt-blown cloth (polypropylene); the nose piece is made of polypropylene & iron (Fe), and the ear loops are made of nylon & spandex.
5. Indications for Use
The disposable medical surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided as sterile and non-sterile.
6. Summary of Technological Characteristics
| Comparison item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Manufacturer | Chongqing COE DisplayTechnology Co., Ltd. | SAN-M PACKAGE CO.,LTD. | Different |
| 510k number | K202759 | K160269 | Different |
| Product name | Disposable medical surgicalmask | Surgical face mask | Similar |
| Product model | CCSM-NC | EL 20000 | Different |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| Intendeduse &Indications forUse | The disposable medicalsurgical masks are intended tobe worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluids,and particulate material. Theseface masks are intended foruse in infection controlpractices to reduce the | The surgical face masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids,and particulate material. Theseface masks are intended foruse in infection controlpractices to reduce the potential exposure to blood | Similar |
| potential exposure to blood and body fluids. This is a single-use, disposable device, provided as sterile and non-sterile | and body fluids. This is a single-use, disposable device, provided non-sterile. | ||
| Mask features | Ear Loops, flat Pleated | Ear Loops, flat Pleated | Same |
| Layers | 3 layers | 4 layers | Different |
| Outer layer | Polypropylene | Polypropylene | Same |
| Filter media | Melt-blown cloth(polypropylene) | Polypropylene spunbondPolypropylene meltblown | Similar |
| Inner layer | Polypropylene | Polypropylene | Same |
| Ear loops | Nylon & Spandex | Ear loops: Polyester, polyurethane | Similar |
| Nose piece | Polypropylene & Iron (Fe) | Polyethylene coated steel wire | Similar |
| Color | Blue | White or Blue | Same |
| Dimension(Length*Width) | Mask body: 17.5cm*9.5cmNosepiece:length: 8cm-12cm; width: 3cmEar loop: 18cm±0.9cm | 17.5cm*9.5cm | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single-use, disposable | Single-use, disposable | Same |
| Performancelevel | Level 3 | Level 3 | Same |
| Fluid ResistancePerformanceASTM F1862 | 32 Out of 32 Pass at160mmHg | 32 Out of 32 Pass at160mmHg | Same |
| ParticulateFiltrationEfficiencyASTM F2299 | Pass at ≥ 98.0% | Pass at 99.72% | Similar |
| BacterialFiltrationEfficiencyASTM F2101 | Pass at ≥98% | Pass at 99% | Similar |
| DifferentialPressureASTM F2100-19 | Pass at 4.6 mm H2O/cm2 | Pass at 2.5 mmH2O/cm2 | Similar |
| CytotoxicityISO 10993-5 | Under the conditions of thestudy, the subject device wasnon-cytotoxic | Under the conditions of thestudy, the subject device wasnon-cytotoxic | Same |
| SensitizationISO 10993-10 | Under the conditions of thestudy, the subject device wasnon-sensitizing | Under the conditions of thestudy, the subject device wasnon-sensitizing | Same |
| IrritationISO 10993-10 | Under the conditions of thestudy, the subject device wasnon-irritating | Under the conditions of thestudy, the subject device wasnon-irritating | Same |
6.1 Comparisons for non-sterile mask
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The subject device only includes level 3 and ear loops type, it was covered by the scopes of predicate device, which includes level 1, level 2 and level 3, as well as types of ear loop.
Both proposed device and predicate device conform to ASTM F2100, the difference is the versions of the standard, the proposed device was tested by the latest version, and this difference will not raise any new issue of safety and effectiveness of the proposed device.
Although the materials, and layers of subject device are a little different from the predicate device, the performance and biocompatibility testing of the subject device meet all the requirements of standards of ASTM F2100 and ISO 10993-5 &-10. So, the differences between the predicate device and subject device will not raise any new issue of safety and effectiveness of the subject device.
| Comparison item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Manufacturer | Chongqing COE DisplayTechnology Co., Ltd. | SAN-M PACKAGE CO.,LTD. | Different |
| 510k number | K202759 | K160269 | Different |
| Product name | Disposable medical surgicalmask | Surgical face mask | Similar |
| Product model | CCSM-SC | EL 20000 | Different |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| Intendeduse &Indications forUse | The disposable medicalsurgical masks are intended tobe worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluids,and particulate material. Theseface masks are intended foruse in infection control | The surgical face masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids,and particulate material. Theseface masks are intended foruse in infection controlpractices to reduce the | Similar |
| practices to reduce thepotential exposure to bloodand body fluids. This is asingle-use, disposable device,provided as sterile and non-sterile | potential exposure to bloodand body fluids. This is asingle-use, disposable device,provided non-sterile. | ||
| Mask features | Ear Loops, flat Pleated | Ear Loops, flat Pleated | Same |
| Layers | 3 layers | 4 layers | Different |
| Outer layer | Polypropylene | Polypropylene | Same |
| Filter media | Melt-blown cloth(polypropylene) | Polypropylene spunbondPolypropylene meltblown | Similar |
| Inner layer | Polypropylene | Polypropylene | Same |
| Ear loops | Nylon & Spandex | Ear loops: Polyester,polyurethane | Similar |
| Nose piece | Polypropylene & Iron (Fe) | Polyethylene coatedsteel wire | Similar |
| Color | Blue | White or Blue | Same |
| Dimension(Length*Width) | Mask body: 17.5cm*9.5cmNosepiece:length: 8cm-12cm; width: 3cmEar loop: 18cm±0.9cm | 17.5cm*9.5cm | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Sterile | Non-sterile | Different |
| Packagingmaterial | Paper plastic bag | Not publicly available | Different |
| Sterilizationmethod andS.A.L. | Sterilized by ethyleneoxide gas, SAL=10-6 | Not applied | Different |
| Residues | MEO≤4mg/d; MECH≤9mg/d | Not applied | Different |
| Shelf life | No shelf life claim | No shelf life claim | Same |
| Use | Single-use, disposable | Single-use, disposable | Same |
| Performancelevel | Level 3 | Level 3 | Same |
| Fluid ResistancePerformanceASTM F1862 | 32 Out of 32 Pass at160mmHg | 32 Out of 32 Pass at160mmHg | Same |
| ParticulateFiltrationEfficiencyASTM F2299 | Pass at ≥ 98.0% | Pass at 99.72% | Similar |
| BacterialFiltrationEfficiencyASTM F2101 | Pass at ≥98% | Pass at 99% | Similar |
| DifferentialPressureASTM F2100-19 | Pass at 4.8 mm H2O/cm² | Pass at 2.5 mmH2O/cm2 | Similar |
| Flammability 16CFR 1610 | Class I | Class I | Same |
| CytotoxicityISO 10993-5 | Under the conditions of thestudy, the subject device wasnon-cytotoxic | Under the conditions of thestudy, the subject device wasnon-cytotoxic | Same |
| SensitizationISO 10993-10 | Under the conditions of thestudy, the subject device wasnon-sensitizing | Under the conditions of thestudy, the subject device wasnon-sensitizing | Same |
| IrritationISO 10993-10 | Under the conditions of thestudy, the subject device wasnon-irritating | Under the conditions of thestudy, the subject device wasnon-irritating | Same |
6.2 Comparisons for sterile mask
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The subject device only includes level 3 and ear loops type, it was covered by the scopes of predicate device, which includes level 1, level 2 and level 3, as well as types of ear loop.
Both proposed device and predicate device conform to ASTM F2100, the difference is the versions of the standard, the proposed device was tested by the latest version, and this difference will not raise any new safety and effectiveness of the proposed device.
Although the materials, layers and sterility status of subject device are a little different from the predicate device, the performance, biocompatibility and EO sterilization of the subject device meet all the requirements of standards of ASTM F2100, ISO 10993-5 &-10 and ISO 11135. So. the differences between the predicate device and subject device will not raise any new issue of safety and effectiveness of the subject device.
7. Brief discussion of Non-Clinical Testing
Surgical Face Mask conforms to the following standards:
ASTM F 2100-19, Standard Specification for Performance of Materials Use in Medical Face Masks.
ISO 10993-1:2018, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.
Bench testing
The bench testing of Surgical Face Mask includes the following tests: *Fluid Resistance Performance *Particulate Filtration Efficiency *Bacterial Filtration Efficiency
*Differential Pressure
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*Flammability
Biocompatibilitv testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the International Standard ISO 10993-1: 2018 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. Biocompatibility evaluation included the following tests:
- · Cytotoxicity
- · Skin Sensitization
- · Skin Irritation
Ethylene oxide Sterilization Validation
The proposed device is also provided for sterilization validation is performed, and the results show that the proposed device complies with the following standards:
- · ISO 11135:2014 Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- ISO 11737-1:2018 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on product
- · ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- ASTM F88-2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
- · ASTM F1929-2015 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
Summarv
Based on the non-clinical performance data as documented above in the device development, the proposed device has a safety and effectiveness profile that is similar to the predicate device, the testing results are summarized in the following table:
| Name of TestMethodology(standard) | Purpose | AcceptanceCriteria | Results | |
|---|---|---|---|---|
| ASTM F 1862-17 | FluidResistancePerformance | 29 out of 32pass at160 mmHg | Lot 1# pass at160mmHg;Lot 2# pass at160mmHg;Lot 3# pass at160mmHg | Lot 1# pass at160mmHg;Lot 2# pass at160mmHg;Lot 3# pass at160mmHg; |
| ASTM F2101-19 | BacterialFiltrationEfficiency | $\ge$ 98% | Lot 1# 99.6%-99.9%;Lot 2# 99.7%-99.9%;Lot 3# 99.6%-99.9% | Lot 1# 99.6%-99.9%;Lot 2# 99.6%-99.8%;Lot 3# 99.7%-99.9% |
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| Performance | ||||
|---|---|---|---|---|
| EN 14683:2019 | DifferentialPressure(Delta-P) | < 6.0mmH2O/cm2 | Lot 1# 4.0-5.2;Lot 2# 4.4-5.4;Lot 3# 3.6-5.2 | Lot 1# 4.0-5.1;Lot 2# 4.1-5.0;Lot 3# 4.3-5.0 |
| ASTM F2299-2007 | ParticulateFiltrationEfficiencyPerformance | ≥ 98% | Lot 1# 98.0%-98.9%;Lot 2# 98.3%-98.9%;Lot 3# 98.3%-98.9% | Lot 1# 98.2%-98.9%;Lot 2# 98.5%-99.1%;Lot 3# 98.6%-99.0% |
| 16 CFR Part1610 | Flammability | Class I | Lot 1# Class I;Lot 2# Class I;Lot 3# Class I | Lot 1# Class I;Lot 2# Class I;Lot 3# Class I |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under the conditions of the study, thesubject device was non-cytotoxic | |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under the conditions of the study, thesubject device was non-sensitizing | |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, thesubject device was non-irritating |
8. Brief discussion of clinical tests
No clinical tests were performed.
9. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202759, the Disposable medical surgical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160269.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.